Identity
- Trade Name
- ZIRCONIA PRIME FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- ZR DIAMOND PARALLEL CHAMFR 5pc FDA UDI
- Model / Reference
- 049019100 FDA UDI
- Description
- ZR DIAMOND PARALLEL CHAMFR 5pc FDA UDI
Identifiers
- Catalog Number
- 049019100 FDA UDI
- Primary DI / UDI-DI
- D8130490191001 FDA UDI
- FDA Product Code
- DZP FDA UDI
- GMDN Term
- Diamond dental bur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4535 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Diamond dental bur, reusable
Zirconia Prime by Den-Mat Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI 5bba21b1-0ab6-417c-a7e2-fbca0ddabd05 35 fields · synced Jun 9, 2026